Treatment of Lower Transsphincteric Perianal Fistula: Fistulotomy With Marsupialization vs Open Wound

Consorci Sanitari de l'Alt Penedès i Garraf

Status: Withdrawn

Conditions: Transsphincteric Anal Fistula; Perianal Fistula

Treatments: Procedure: Fistulotomy with marsupialization; Procedure: Fistulotomy with open wound

Study type: Interventional

Funder types: Other

Identifiers

NCT04722965

CSAPG-13

Details and patient eligibility

About

This study will compare the results of marsupialization versus open wound after fistulotomy in low transsphincteric perianal fistulas.

Full description

This is a multi-center triple blinded randomized clinical trial in which we'll compare two techniques for the treatment of simple low transsphincteric perianal fistulas. 40 patients will undergo a fistulotomy with marsupialization and 40 patients will undergo a fistulotomy with open wound. There will be an inclussion visit in which personal information will be recorded and the consent will be signed. Randomization will be done after inclusion, following a balanced blocks model. Information of the surgery technic won't be available for the investigator. The patients will have a journal in which they'll write their postoperative symptoms. Follow up will be done at weeks 2, 4 and 6 by the main investigator of each center. Data will be based in clinical examination, patient's diary and medical records. Statistical analysis of the primary outcome will be based in a superiority analysis using the Mantel-Cox test, or in case needed, a multivariate Cox regression analysis. The secondary outcomes will be analyzed by comparing times, percentages, mean or median with parametric or non parametric tests as it corresponds.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Low transsphinteric perianal fistula, defined as a single tract in the lower third of the anal sphincter, confirmed by ultrasound and intraoperative evaluation.
• Ability to understand the study, to sign the consent and to complete the follow-up.

Exclusion criteria

• Under 18 years of age.
• Complex/recurrent fistula.
• Patients in which by clinical criteria is decided not to perform a fistulotomy.
• Anorectal malignancy.
• Crohn's desease.
• ASA IV or other contraindication for surgery.
• Inmunosuppressed patients or in treatment with steroids or cytotoxic drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Fistulotomy with marsupialization

Active Comparator group

Description:

40 patients with a simple low transsphincteric anal fistula. A fistulotomy with marsupialization is performed.

Treatment:

Procedure: Fistulotomy with marsupialization

Fistulotomy with open wound

Active Comparator group

Description:

40 patients with a simple low transsphincteric anal fistula. A fistulotomy leaving the wound open is performed.

Treatment:

Procedure: Fistulotomy with open wound